About
Shankhapushpi (Convolvulus pluricaulis) is a perennial Ayurvedic herb native to the Indian subcontinent, used traditionally as a brain tonic, nervine tonic, and nootropic to improve memory and intellect. It is used in food supplements, nutraceutical products, and Ayurvedic formulations for neurological and CNS conditions.
Safety summary
The herb has a long history of traditional use in India with a generally favourable safety profile at typical Ayurvedic doses; an acute toxicity study classified the hydroalcoholic leaf extract under OECD category 4 (low acute hazard). No formal ADI has been established by any major international regulatory body (EFSA, FDA, WHO/JECFA), and no IARC carcinogenicity classification exists. Adulteration is a significant practical safety concern, as multiple unrelated plant species are sold under the same name, leading to inconsistent efficacy and potential unknown toxicity.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| FDA (Food and Drug Administration) (United States) | Restricted | Shankhapushpi is not listed as GRAS or as an approved food additive by the FDA. It may be marketed as a dietary supplement ingredient under DSHEA (Dietary Supplement Health and Education Act), but therapeutic claims are not permitted. FDA has not conducted a formal safety evaluation.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Shankhapushpi (Convolvulus pluricaulis) is recognized as a permitted botanical ingredient under FSSAI's Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food Regulations, 2016. It is also covered under the FSSAI Ayurveda Aahara Regulations, 2022. No specific maximum daily intake has been codified for food/supplement use; dosage is governed by traditional Ayurvedic practice and manufacturer labelling.source |
| EFSA (European Food Safety Authority) (European Union) | Under_review | Convolvulus pluricaulis does not appear on the EU authorised novel foods list and has no established E-number. If used as a food ingredient or supplement without a history of significant consumption in the EU before May 1997, it would require a novel food authorisation under EU Regulation 2015/2283. No EFSA opinion has been issued specifically on this herb.source |
Who should approach with care
Research citations
- 1PubMed. Evaluation of CNS Depressant and Anti-anxiety Activities of Leaves of Convolvulus pluricaulis, 2023. pubmed.ncbi.nlm.nih.gov
- 2PubMed. Role of Shankhpushpi (Convolvulus pluricaulis) in neurological disorders: An umbrella review covering evidence from ethnopharmacology to clinical studies, 2022. pubmed.ncbi.nlm.nih.gov
- 3PubMed. Phytochemical Profile, Pharmacological Attributes and Medicinal Properties of Convolvulus prostratus - A Cognitive Enhancer Herb for the Management of Neurodegenerative Etiologies, 2020. pubmed.ncbi.nlm.nih.gov
- 4PubMed. Convolvulus pluricaulis (Shankhapushpi) ameliorates human microtubule-associated protein tau (hMAPτ) induced neurotoxicity in Alzheimer's disease Drosophila model, 2019. pubmed.ncbi.nlm.nih.gov
- 5FSSAI. Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016, 2016. fssai.gov.in
